Saturday, December 23, 2023 1:08:06 AM
Your assertion defies logic. 😶
Let’s consider a simple hypothetical scenario: What if a company submitted an application based on a P3 trial but patients in a subsequent P1 combo trial were dropping dead of complications? According to your logic, the regulators should ignore those P1 data?
All clinical data that exist at the time of a filing with regard to a novel technology are relevant—it’s common sense.
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
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